Lyme BorreliosisCXCL13-LYMENCT05625100
Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis
An observational study of Lyme Borreliosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Neuroborreliosis (NBL) is diagnosed in 10-15% of patients with Lyme borreliosis. In Europe in adults, the main clinical manifestation is called "Bannwarth syndrome". This includes painful meningoradiculitis, sometimes accompanied by cranial nerve neuritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyme Borreliosis
- How many people
- 141 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Major subject (≥18 years old) subject having consulted at the HUS between 01/01/2013 and 31/12/2018
Who may be able to join
- Major subject (≥18 years old)
- Subject having consulted at the HUS between 01/01/2013 and 31/12/2018
- Subject not having, after being informed, expressed their opposition to the reuse of their data for the purposes of this research
Who cannot join
- Subject who expressed their opposition to participating in the study
- Subject under guardianship or curatorship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Laboratoire de Bactériologie - Plateau Technique de Microbiologie - CHU de Strasbourg - France
Strasbourg, 67091
Benoit JAULHAC, MD, PhD, 33 3 69 55 14 52, benoit.jaulhac@chru-strasbourg.fr
Benoit JAULHAC, MD, PhD
About this study
Neuroborreliosis (NBL) is diagnosed in 10-15% of patients with Lyme borreliosis. In Europe in adults, the main clinical manifestation is called "Bannwarth syndrome". This includes painful meningoradiculitis, sometimes accompanied by cranial nerve neuritis. Current European guidelines issued by the European Federation of Neurological Societies (EFNS) recommend the following triad for the diagnosis of "definite NBL": (i) Neurological symptoms suggestive of NBL without any other obvious cause; (ii) CSF pleocytosis; (iii) Intrathecal production of specific anti-Borreliella antibodies. CXCL13, C-X-C chemokine motif ligand 13, is a chemokine implicated in B cell chemotaxis. Extensive literature exists on the analysis of CXCL13i as a diagnostic marker for acute NBL. A recent meta-analysis from 2018, published by Rupprecht et al finds an overall sensitivity and specificity of 89% and 96% respectively, indicating satisfactory diagnostic value. In this study, the investigators wish to assess the place of this new marker in the diagnosis of neuroborreliosis before proposing it as a test carried out by the Borrelia CNR.
- Conditions
- Lyme Borreliosis
- Keywords
- Lyme borreliosis, Lyme neuroborreliosis, Bannwarth syndrome, Intrathecal CXCL-13
- Medical subject headings
- Lyme Disease, Lyme Neuroborreliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity of the marker (CXCL13-intrathecal) for known cases of NBL and negativity of this one for known non-NBL cases
Measured: Files analysed retrospectively from January 01, 2013 to December 31, 2018 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start13 Jul 2020
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme BorreliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625100
- Sponsor's protocol ID
- 7885
- Acronym
- CXCL13-LYME
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis
- ClinicalTrials.gov ID
- NCT05625100
- Acronym / sponsor ID
- CXCL13-LYME / 7885
- Conditions
- Lyme Borreliosis
- Keywords
- Lyme borreliosis, Lyme neuroborreliosis, Bannwarth syndrome, Intrathecal CXCL-13
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuroborreliosis (NBL) is diagnosed in 10-15% of patients with Lyme borreliosis. In Europe in adults, the main clinical manifestation is called "Bannwarth syndrome". This includes painful meningoradiculitis, sometimes accompanied by cranial nerve neuritis. Current European guidelines issued by the European Federation of Neurological Societies (EFNS) recommend the following triad for the diagnosis of "definite NBL": (i) Neurological symptoms suggestive of NBL without any other obvious cause; (ii) CSF pleocytosis; (iii) Intrathecal production of specific anti-Borreliella antibodies. CXCL13, C-X-C chemokine motif ligand 13, is a chemokine implicated in B cell chemotaxis. Extensive literature exists on the analysis of CXCL13i as a diagnostic marker for acute NBL. A recent meta-analysis from 2018, published by Rupprecht et al finds an overall sensitivity and specificity of 89% and 96% respectively, indicating satisfactory diagnostic value. In this study, the investigators wish to assess the place of this new marker in the diagnosis of neuroborreliosis before proposing it as a test carried out by the Borrelia CNR.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years old) subject having consulted at the HUS between 01/01/2013 and 31/12/2018
Key inclusion criteria (3 listed)
- Major subject (≥18 years old)
- Subject having consulted at the HUS between 01/01/2013 and 31/12/2018
- Subject not having, after being informed, expressed their opposition to the reuse of their data for the purposes of this research
Key exclusion criteria (3 listed)
- Subject who expressed their opposition to participating in the study
- Subject under guardianship or curatorship
- Subject under safeguard of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positivity of the marker (CXCL13-intrathecal) for known cases of NBL and negativity of this one for known non-NBL cases
Time frame: Files analysed retrospectively from January 01, 2013 to December 31, 2018 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Borreliosis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benoit JAULHAC, MD, PhD (33 3 69 55 14 52, benoit.jaulhac@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positivity of the marker (CXCL13-intrathecal) for known cases of NBL and negativity of this one for known non-NBL cases (time frame: Files analysed retrospectively from January 01, 2013 to December 31, 2018 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.